Erin Brockovich leading campaign against Essure

It is supposed to be a safe and painless form of permanent birth control, but thousands of women around the country -- including many in Western Pennsylvania -- say it's actually causing them tremendous pain and long-term damage.

Yet the law prevents these women from suing the company that makes the device.

The device is called Essure and it is touted as a safe alternative to tubal ligation, otherwise known as tube-tying.

After extensive testing, the Food and Drug Administration said Essure was safe and put it in a class that exempts manufacturers -- in this case, Bayer -- from lawsuits.

Now, environmental activist Erin Brockovich is taking on the company -- and the law -- on behalf of women who say they are suffering.

After Beth Shoop had her second child in just two years, she decided to get sterilized. Her doctor recommended Essure.

"She goes, 'One to two recovery days and, boom, you're good to go. It sounded real good," Shoop said.

Here's how Essure works: The doctor inserts coils into a woman's Fallopian tubes. Then the body forms a natural barrier around the coils that prevents sperm from reaching the eggs.

It's non-invasive and, supposedly, pain-free, but from the moment she came out of surgery, Shoop was in tremendous pain.

"I was crying because I was in so much pain. My legs hurt. They were cramping," she said.

It only got worse -- so bad, she could not even care for her two young children. "I had to use a walker because I couldn't walk on my own," Shoop said. "I had to hold onto something because the back pain, the pelvic pain was so bad."

Her doctors could not figure out what was causing the problem. Eventually the doctor who inserted the coils removed them and did a tubal ligation.

Almost immediately, Shoop says her health improved. Later, she filed a complaint with the FDA.

FDA records show 698 women have filed complaints about Essure in just the past five years. Most women have complained about painful side effects. But some have said they got pregnant even after getting the procedure.

Shoop also found a Facebook page and a website where thousands of women who had the Essure procedure described symptoms similar to hers. That includes Patricia Nuckolls of Charleroi.

What's it like to live with all those symptoms? "Honestly, day by day, it's very difficult," Nuckolls said.

"It's been hard seeing her sick a lot, hunched over and in pain a lot," added her husband, Bryan Nuckolls.

Dr. John Fisch has done hundreds of Essure procedures and said he has had very few complaints. But with 750,000 women getting the coils during the past decade, he is not surprised there are complications.

"Sure, there are people who do not do well with the procedure," Fisch said. "But all in all, for the majority of patients, it's a very safe and effective procedure."

Bayer, whose North American headquarters is in Robinson Township, also defends Essure. The company sent a statement that said, in part, "Essure…has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness.”

But with thousands of women complaining, Brockovich said the company needs to do more. She said so many of those women contacted her that she began a campaign against Essure.

"Hear these women. If necessary, take the product off the market. Take a look at it and make sure it is safe before you put it back out there," Brockovich said.

She is also pushing Congress to repeal the law that gives Essure and other medical devices special protection, making them immune from lawsuits.

The law is aimed at encouraging companies to sell devices that could get them sued. The FDA does additional testing on these products before they can be sold -- and in exchange for those delays. companies get the lawsuit exemption.

The FDA declined to comment on Essure, citing the government shutdown.

3 It's billed as safe and painless birth control. But thousands of women around the country - Including many in our area - Say they've suffered tremendous pain and long-term damage. And here's the catch. The law prevents those women from suing the company that makes the device. INVESTIGATIVE REPORTER PAUL VAN OSDOL IS LIVE WITH THE STORY - PAUL? 3 3 The device is called Essure and it's touted as a safe alternative to tubal ligation - otherwise known as tube-tying. After extensive testing the FDA said Essure was safe and even put it in a class that exempts manufacturers - in this case Bayer - from lawsuits. Now the environmental activist Erin Brockovich is taking on the company - and the law - on behalf of suffering. 3 After Beth Shoop had her second child in just two years, she decided to get sterilized. Her doctor recommended Essure. 3 Here's how Essure works: The doctor inserts coils into a woman's fallopian tubes. Then the body forms a natural barrier around the coils that prevents sperm from reaching the eggs. It's non-invasive and - supposedly- pain-free. But from the moment 3 she came out of surgery, Beth was in tremendous pain. 3 It only got worse.So bad she could not even care for her two young children. 3 Her doctors could not figure out what was causing the problem. Eventually the doctor who inserted the coils removed them and did a tubal ligation. Almost immediately Beth says her health improved.Later she filed a complaint with the FDA. FDA records show in just the past five years, 698 women have filed complaints about Essure. Most women have complained about painful side effects.But some have said they got pregnant even after getting the procedure. Beth also found a Facebook page and a website where thousands of women who had the Essure procedure described symptoms similar to hers. 3 Including Patricia Nuckolls of Charleroi. 3 Doctor John Fisch has done hundreds of Essure procedures and he says he has had very few complaints.But with 750-thousand women getting the coils during the past decade, he is not surprised there are complications. 3 Bayer - whose North American headquarters is in Robinson Township - also defends Essure. The company sent a statement that says in part, Essure has a well- documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting its safety, efficacy and cost- effectiveness.But with thousands of women complaining - activist Erin Brockovich says the company needs to do more. She says so many of those women contacted her that she began a campaign against Essure. 3 3 She is also pushing Congress to repeal the law that gives Essure and other medical devices special protection, making them immune from lawsuits. The law is aimed at encouraging companies to sell devices that could get them sued. The FDA does additional testing on these products before they can be sold - and in exchange for those delays companies get the lawsuit exemption. Weeks ago I tried contacting the FDA but they did not respond. Finally I heard from them last week and a spokesman said they could not comment - because of the government shutdown. 3 3 3 3